Quality Control PChem Analyst I or II

Description

Clene is looking for a motivated Quality Control P-Chem Analyst I or II to join our Quality Control team. In this role, you will perform analytical testing on bioanalytical and production samples while helping ensure the quality, safety, integrity, and compliance of our products. This is an excellent opportunity for a laboratory professional who enjoys hands-on analytical work and wants to grow within a collaborative, science-driven environment focused on quality, continuous improvement, and operational excellence.

The Analyst I or Analyst II level will be based on your education, laboratory experience, technical skills, and demonstrated level of independence.

We offer a competitive benefits package, including:

• Up to 4 weeks of paid time off.
• Paid holidays.
• Medical, dental, vision, and prescription coverage for employees & eligible dependents.
• 401(k) retirement plan with employer match
  .
• Opportunities for professional growth and continued learning.
• Stable, full-time employment.

As a Quality Control P-Chem Analyst you will perform analytical testing on bioanalytical and production samples received from contract research organizations, manufacturing operations, and Research & Development. You will perform testing in accordance with current Good Manufacturing Practices (cGMP), Good Laboratory Practices (cGLP), Standard Operating Procedures (SOPs), validated test methods, and established laboratory procedures.

The position requires strong attention to detail, sound analytical judgment, accurate documentation, and the ability to identify and communicate laboratory or analytical issues that may affect product quality, compliance, or laboratory operations.

Your duties and responsibilities will include, but not limited to:

• Perform analytical testing of bioanalytical specimens, including blood, urine, and tissue samples.
• Analyze production and research samples using laboratory instrumentation and established analytical techniques.
• Operate, maintain, calibrate, and troubleshoot laboratory equipment and analytical instrumentation.
• Execute analytical methods in accordance with approved Test Methods (TSMs), SOPs, protocols, and validated procedures.
• Accurately document analytical activities, observations, calculations, results, and equipment use in accordance with applicable requirements.
• Review analytical data for accuracy, completeness, and compliance with established acceptance criteria.
• Identify, investigate, and communicate analytical, equipment, or procedural issues that may affect product identity, strength, quality, purity, compliance, or laboratory efficiency.
• Assist with laboratory equipment qualification, validation, calibration, and maintenance activities.
• Support laboratory investigations, deviations, out-of-specification/out-of-trend investigations, and corrective and preventive actions, as applicable to the position level.
• Assist in the preparation, revision, review, and maintenance of test methods, SOPs, protocols, reports, and other quality documentation.
• Support Research & Development projects and analytical laboratory investigations.
• Maintain laboratory inventory, Safety Data Sheets (SDS), and assist with purchasing laboratory supplies.
• Complete required training and maintain current training records.
• Participate in continuous improvement initiatives designed to improve laboratory efficiency, quality, compliance, and reliability.
• Communicate effectively with Quality Assurance, Quality Control, Manufacturing, Research & Development, and other departments as required.
• Perform other duties as assigned.

Quality…